Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

Smoking Cessation Clinical Trial

Official title:

Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286402
• Other study ID #: HSC-MS-09-0681
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2011
• Last updated: January 5, 2016
• Start date: April 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.

Description:

A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women = 18 years of age

• Gestational age between 14 and 26 weeks confirmed by ultrasound

• Currently smoking = 5 cigarettes per day

Exclusion Criteria:

• Abnormal liver function tests

• History of or current seizure disorder or closed head injury with loss of consciousness

• Known hypersensitivity to bupropion

• Any psychiatric disorder requiring psychotropic medication

• Current anorexia or bulimia

• Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks

• Major Depressive Disorder or current suicidal risk

• Use of any illicit substances since receiving knowledge of pregnancy

• Regular use of alcohol (>1 drink/week on average)

• Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus

• Twins or other multiple gestation

• Fetal abnormality on the 14 week ultrasound

• Plans to deliver at a hospital other than Memorial Hermann

• Inability to communicate with research staff or make study visits due to lack of phone or transportation access

• Participation in another clinical study which may affect study outcomes

• Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Bupropion SR
150mg, taken orally, taken daily for the 1st 3 days 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment

Other:
• Placebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston, Professional Building	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Gilstrap, Larry C, M.D., M.D. Anderson Cancer Center, The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment		1 week post treatment	No
Secondary	Enrollment, Retention and Compliance Rates		1 year (estimated)	No
Secondary	Continuous Abstinence From End of Treatment Through the 2 Week Followup		at two week followup visit	No
Secondary	Continuous Abstinence From Birth to 2nd Week Postpartum Followup		at 2nd week postpartum followup visit	No
Secondary	Self-reported Reduction in Number of Cigarettes Smoked Per Day		at 1 week post treatment and at 2 week postpartum visit	No
Secondary	Maternal Side Effects		during treatment, end of treatment and at 2 week postpartum visit	Yes
Secondary	Perinatal/Neonatal Outcomes		at neonatal discharge from hospital following delivery	Yes